Phase 4
Completed N=8,053
Local Phase 4 Pan-European SMART Study
Source: ClinicalTrials.gov NCT00463866 ↗Enrolled (actual)
8,053
Serious AEs
2.1%
Results posted
Mar 2010
Primary outcomePrimary: Number of Severe Asthma Exacerbations Per Participant. — 0.097; 0.080 Severe exacerbations per participant
Summary
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Severe Asthma Exacerbations Per Participant. |
0.097; 0.080 | — |
| SECONDARY Fraction of Participants With Severe Asthma Exacerbation |
0.09686; 0.07955 | — |
| SECONDARY Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. |
0.0120; 0.0091 | — |
| SECONDARY Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation |
9.6; 9.1 | — |
| SECONDARY Mean Daily Number of Inhalations of As-needed Medication. |
0.897; 0.625 | — |
| SECONDARY Percent of Participants With a Well Controlled Asthma Week. |
43.69; 54.26 | — |
| SECONDARY Mean Overall Asthma Control Questionnaire (ACQ) Score |
1.18; 1.089 | — |
| SECONDARY The Mean Total Daily Dose of Steroids From Symbicort. |
462.96; 736.58 | — |
| SECONDARY Mean Cost Per Participant Per Country |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients at out-patient clinics
- >18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief
Exclusion Criteria
- Asthma exacerbation within the last 14 days prior to study start
- subject aged >40 years with a smoking history of >10pack-years
- subjects with chronic obstructive lung disease or other significant respiratory disease
Data sourced from ClinicalTrials.gov (NCT00463866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.